Sedative/Hypnotics - Index

Medications listed in the tables and non-FDA approved indications included in these retrospective criteria are not indicative of Texas Vendor Drug Program formulary coverage.

  • Revision history
    • Jan. 20, 2023
    • Jan. 22, 2021
    • May 2018
    • May 2016
    • March 2016
    • Aug. 2014
    • May 2014
    • March 2014
    • March 2012
    • May 2010
    • Nov. 2006
    • Aug. 2006
    • July 2006
    • Dec. 2003
    • Oct. 2002
    • Nov. 2001
    • Oct. 2000
    • Dec. 1999
    • Nov. 1998
    • Nov. 1997
    • Nov. 1996
  • Initially developed
    • Jan. 1995

1.1. Adults

Maximum recommended daily doses for sedative/hypnotics in adults, including the elderly population, are summarized in Table 1. Prescribed dosages exceeding these recommendations will be reviewed.

Table 1. Maximum Recommended Daily Dosages for Sedative/Hypnotics in Adults: Benzodiazepines1-7
Drug Name Dosage Form/ Strength Maximum Recommended Dosage: Less than or equal to 65 years Maximum Recommended Dosage: Greater than 65 years
estazolam (generics) 1 mg, 2 mg tablets 2 mg 2 mg*
flurazepam (generics) 15 mg, 30 mg capsules 30 mg 15 mg*
temazepam (Restoril®, generics) 7.5 mg, 15 mg, 22.5 mg, 30 mg capsules 30 mg 30 mg*
triazolam (Halcion®, generics) 0.125 mg, 0.25 mg tablets 0.5 mg 0.25 mg*
quazepam (Doral®, generics) 15 mg tablets 15 mg 15 mg*

Legend:

  • * In elderly patients (patients greater than 65 years of age), sedative/hypnotic dosages should be reduced, if possible, as these patients are more sensitive to sedative/hypnotic pharmacologic/adverse effects24.
CaptionXXX
Drug Name Dosage Form/ Strength Maximum Recommended Dosage: Less than or equal to 65 years Maximum Recommended Dosage: Greater than 65 years
phenobarbital+ (generics) 15 mg, 16.2 mg, 30 mg, 32.4 mg, 60 mg, 64.8 mg, 97.2 mg, 100 mg tablets; 20 mg/5 mL elixir 400 mg 400 mg*

Legend:

  • + No longer considered acceptable drug class to manage insomnia as safer agents (i.e., benzodiazepines, nonbarbiturates) are available25.
  • * In elderly patients (patients greater than 65 years of age), sedative/hypnotic dosages should be reduced if possible, as these patients are more sensitive to sedative/hypnotic pharmacologic/adverse effects24.
Table 3. Maximum Recommended Daily Dosages for Sedative/Hypnotics in Adults: Non-Benzodiazepine, Benzodiazepine Receptor Agonists1,2,10-17
Drug Name Dosage Form/ Strength Maximum Recommended Dosage: Less than or equal to 65 years Maximum Recommended Dosage: Greater than 65 years
eszopiclone (Lunesta®, generics) 1 mg, 2 mg, 3 mg tablets 3 mg 2 mg
zaleplon (generics) 5 mg, 10 mg capsules 20 mg 10 mg
zolpidem immediate-release (IR) (Ambien®, generics) 5 mg, 10 mg IR tablets 10 mg 5 mg
zolpidem extended-release (ER) (Ambien CR®, generics) 6.25 mg, 12.5 mg ER tablets 12.5 mg 6.25 mg
zolpidem sublingual tablets (Edluar®) 5 mg, 10 mg sublingual tablets 10 mg 5 mg
zolpidem sublingual tablets (generics) 1.75 mg, 3.5 mg sublingual tablets 1.75 mg  (women)
3.5 mg  (men)		 1.75 mg
zolpidem lingual spray (Zolpimist®) 5 mg/ actuation 10 mg 5 mg
Table 4. Maximum Recommended Daily Dosages for Sedative/Hypnotics in Adults: Melatonin Receptor Agonists1,2,18,19
Drug Name Dosage Form/Strength Maximum Recommended Dosage: Less than or equal to 65 years Maximum Recommended Dosage: Greater than 65 years
ramelteon (Rozerem®) 8 mg tablets 8 mg 8 mg
ramelteon (Rozerem®, generics) 8 mg tablets 8 mg 8 mg
Table 5. Maximum Recommended Daily Dosages for Sedative/Hypnotics in Adults: Orexin Receptor Antagonists1,2,20-22
Drug Name Dosage Form/Strength Maximum Recommended Dosage: Less than or equal to 65 years Maximum Recommended Dosage: Greater than 65 years
daridorexant (Quviviq®) 25 mg, 50 mg 50 mg 50 mg
lemborexant (Dayvigo®) 5 mg, 10 mg tablets 10 mg 10 mg
suvorexant (Belsomra®) 5 mg, 10 mg 15 mg, 20 mg tablets 20 mg 20 mg
Table 6. Maximum Recommended Daily Dosages for Sedative/Hypnotics in Adults: Miscellaneous Nonbarbiturates1,2,23
Drug Name Dosage Form/Strength Maximum Recommended Dosage: Less than or equal to 65 years Maximum Recommended Dosage: Greater than 65 years
doxepin (Silenor®, generics) 3 mg, 6 mg tablets 6 mg 6 mg

In the elderly, short- and intermediate-acting benzodiazepines (e.g., temazepam, triazolam) are preferred, as long-acting benzodiazepines (e.g., flurazepam) are associated with increased sedation and an increased risk of falls and fractures in this patient population.

The appropriate sedative/hypnotic dose for debilitated patients is the same as that prescribed in elderly patients for most sedative/hypnotic agents. However, estazolam 0.5 mg is used in small or debilitated geriatric patients, a dose lower than that recommended for elderly patients.

Doxepin is FDA-approved for use in managing insomnia characterized by difficulty in maintaining sleep. Studies have documented efficacy for up to 3 months in duration.

Patients with hepatic insufficiency have a reduced clearance of zolpidem. A 5 mg zolpidem immediate-release, sublingual (Edluar®), or oral spray (Zolpimist®) dose, a 1.75 mg sublingual tablet (Intermezzo®) dose, or a 6.25 mg extended-release dose is recommended in these patients.

Eszopiclone should be used cautiously in patients with severe hepatic impairment with initial doses of 1 mg daily at bedtime, as eszopiclone is significantly hepatically metabolized and serum concentrations may increase substantially in this patient population.

Suvorexant and lemborexant are newer sedative/hypnotics with a novel mechanism of action. Known as orexin receptor antagonists, suvorexant and lemborexant works by altering signaling of the orexin neurotransmitters in the brain. Orexins are responsible for regulating the sleep-wake cycle and helping to keep people awake. Suvorexant was FDA-approved in August 2014 as a schedule IV-controlled substance to manage insomnia associated with difficulties in sleep onset and/or sleep maintenance. Lemborexant was FDA-approved in December 2019 as a schedule IV-controlled substance for the treatment of insomnia characterized by difficulties with sleep onset and/ or sleep maintenance.

1.2. Pediatrics

Safety and efficacy of eszopiclone, ramelteon, zaleplon, zolpidem, daridorexant, lemborexant or suvorexant, as well as sedative/hypnotic benzodiazepines, have not been established in pediatric patients1-22. Barbiturates are no longer recommended for use in pediatric insomnia as safer, more effective agents are available.

2. Duration of Therapy

In adults, insomnia is classified based on symptom duration. Periods of sleep difficulty lasting from one to three nights are classified as situational insomnia, periods lasting less than three months are classified as short-term insomnia, while chronic or long-term insomnia represents sleep difficulties exceeding three months occurring at least three nights per week25-27.

Acute, situational insomnia is due to minor situational, familial, and/or occupational stress and is managed primarily by teaching patients to re-establish normal sleep-wake patterns.26 Short-term insomnia is precipitated by events such as divorce, job loss, health concerns, or prescription medications and may be managed by behavioral techniques, lifestyle changes, and, if necessary, short-term pharmacologic therapy27.

Long-term insomnia may be associated with medical or psychiatric illness (e.g., mood and anxiety disorders, asthma, chronic pain, and gastroesophageal reflux) as well as a variety of prescribed medications, although approximately 40% of patients may develop chronic insomnia due to psychophysiological characteristics27-28. Chronic insomnia with a psychophysiological component is characterized by a marked over concern about the inability to fall asleep29 . A definitive diagnosis of the specific cause for long-term insomnia is necessary before a treatment plan can be delineated27, 30. Sedative/hypnotics are generally reserved for use in those patients with insomnia in whom secondary causes of insomnia have been evaluated and managed or in whom sleep hygiene practices have failed.30 Chronic insomnia without underlying medical or psychiatric disease can be managed most effectively with a benzodiazepine or nonbenzodiazepine hypnotic used concurrently for a finite period with daily behavioral therapy31. Ideally, sedative/hypnotics are not routinely recommended for the management of chronic insomnia25, 29. However, in certain circumstances (e.g., severe, refractory insomnia, chronic comorbid illnesses), benzodiazepine and nonbenzodiazepine hypnotics may be administered in conjunction with non-pharmacologic behavioral therapy in the lowest effective dose several times per week for extended durations29. Hypnotics should typically be dosed intermittently once every two to three nights to avoid tolerance and dependence29 . Recently, though, eszopiclone and ramelteon have been approved for use in the long-term management of sleep onset and/or sleep maintenance insomnia, while zolpidem extended-release has been approved for use in managing insomnia for up to 24 weeks to treatment duration10,11,14,18,19.

Suvorexant, lemborexant, and daridorexant, the most recently approved medications for insomnia, are prescribed to help patients with sleep onset and sleep maintenance. These drugs may be prescribed on a nightly basis if patients can remain in bed for at least 7 hours before the scheduled waking time20-22.

Zolpidem immediate-release prescribed quantities should not exceed four to five weeks supply13. Barbiturates are indicated for short-term treatment of insomnia, as these agents appear to lose effectiveness in sleep induction and maintenance after 2 weeks8, 9.

Sedative/hypnotic treatment regimens lasting longer than four months in adult patients will be reviewed.

In pediatric patients, sedative/hypnotics are primarily used to alleviate anxiety and/or pain associated with painful or nonpainful but threatening procedures.

3. Duplicative Therapy

The concurrent use of two or more sedative/hypnotics is not recommended. Additional therapeutic benefit is not appreciated when several sedative/hypnotics are administered in combination. Patient profiles containing concurrent prescriptions for multiple sedative/hypnotics will be reviewed.

4. Drug-Drug Interactions

Patient profiles will be assessed to identify those drug regimens that may result in clinically significant drug-drug interactions. Drug-drug interactions considered clinically relevant for sedative/hypnotics are summarized in Table 7. Only those drug-drug interactions identified as clinical significance level 1 or those considered life-threatening which have not yet been classified will be reviewed.

Table 7. Sedative/Hypnotic Drug-Drug Interactions1-23
Target Drug Interacting Drug Interaction Recommendation Clinical Significance Level#
barbiturates (BARB) anticoagulants BARB induction of apixaban, rivaroxaban, and warfarin metabolic clearance (CYP3A4) with potential for decreased anticoagulant clinical effects avoid combination, if possible; closely monitor international normalized ratio (INR) when BARB therapy added, discontinued, or changed to warfarin; addition of warfarin to chronic BARB regimen more tolerable apixaban, rivaroxaban: major, warfarin: moderate (Micromedex) apixaban, rivaroxaban: 2-major, warfarin: 3-moderate (CP)
barbiturates cyclosporine BARB induction of cyclosporine metabolic clearance (CYP3A4) with potential for reduced cyclosporine clinical effects avoid concurrent therapy, if possible; if combination necessary, monitor for cyclosporine immunosuppressive efficacy; monitor cyclosporine serum concentrations when BARB therapy added, discontinued, or changed Moderate (Micromedex), 2-major (CP)
 
barbiturates oral contraceptives (OC) BARB induction of estrogen/ progestin hepatic metabolic clearance with potential for decreased OC clinical effects and risk of contraceptive failure OCs with higher ethinyl estradiol dosages (e.g., 50 mcg) to increase contraceptive efficacy may be necessary; second contraceptive method recommended to prevent unwanted pregnancy Major (Micromedex), 3-moderate (CP)
barbiturates voriconazole BARB induction, especially long-acting BARBs (phenobarbital), of voriconazole metabolic clearance (CYP3A4) with potential for decreased voriconazole clinical effects voriconazole contraindicated for use with long-acting BARBs; use cautiously with short-acting BARBs and monitor clinical effects contraindicated (DrugReax), 1-contraindicated (CP)
daridorexant strong CYP3A4 inhibitors (e.g., ketoconazole, protease inhibitors, macrolides) potential for increased daridorexant plasma concentrations and enhanced pharmacologic/ adverse effects Concurrent administration is not recommended major (Micromedex), 2-major (CP)
daridorexant moderate CYP3A4 inhibitors (e.g., ketoconazole, protease inhibitors, macrolides) potential for increased daridorexant plasma concentrations and enhanced pharmacologic/adverse effects if used concomitantly, the dose of daridorexant should not exceed 25 mg once per night major (Micromedex), 2-major (CP)
daridorexant CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine) potential for decreased daridorexant exposure and risk of reduced efficacy avoid concurrent therapy, if possible major (Micromedex), 2-major (CP)
doxepin drugs metabolized by CYP2D6 (e.g., phenothiazines, delavirdine) potential for increased doxepin serum levels and enhanced pharmacologic/ adverse effects due to competition for CYP2D6 metabolic pathway concurrent administration is not recommended; monitor patients for enhanced doxepin effects; adjust doses as necessary Major (Micromedex), 2-major (CP)
eszopiclone CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine) induction of eszopiclone metabolic clearance (CYP3A4) with potential for decreased eszopiclone clinical effects monitor patients for decreased eszopiclone efficacy; consider hypnotic agent not metabolized by CYP3A4 3-moderate (CP)
eszopiclone CYP3A4 inhibitors (e.g., ketoconazole, protease inhibitors, macrolides) potential for increased eszopiclone serum concentrations and enhanced pharmacologic/adverse effects monitor patients for enhanced eszopiclone effects; adjust doses as necessary Major (Micromedex), 3-moderate (CP)
lemborexant CYP3A inducers potential for decreased lemborexant exposure and risk of reduced efficacy monitor patients for decreased efficacy; consider alternate therapy if possible Major (Micromedex), 2- major (CP)
oxidatively metabolized benzodiazepines (BZDs) (e.g., estazolam, triazolam) imidazole antifungals (e.g., itraconazole, ketoconazole) potential for increased serum concentrations and enhanced pharmacologic/ adverse effects in oxidatively metabolized BZDs (metabolized by CYP3A4) as imidazole antifungals inhibit CYP3A4 adjunctive therapy with imidazole antifungals and oxidatively metabolized BZD contraindicated; BZD metabolized by glucuronidation (e.g., temazepam) may be acceptable alternative contraindicated (DrugReax), 2-major, 3-moderate (CP)
oxidatively metabolized BZDs (e.g., estazolam, triazolam) macrolides potential for increased serum concentrations and enhanced pharmacologic/ adverse effects in oxidatively metabolized BZDs (metabolized by CYP3A4) as macrolides inhibit CYP3A4 adjunctive therapy with macrolides and oxidatively metabolized BZD not recommended; BZD metabolized by glucuronidation (e.g., temazepam) may be acceptable alternative; azithromycin may be macrolide alternative (not metabolized by CYP3A4) major (Micromedex), triazolam: 1-contraindicated; estazolam: 3-moderate (CP)
oxidatively metabolized benzodiazepines (e.g., estazolam, triazolam) nefazodone potential for increased serum concentrations and enhanced pharmacologic/ adverse effects (e.g., prolonged sedation, excessive hypnotic effects) in oxidatively metabolized BZDs (metabolized by CYP3A4) as nefazodone potently inhibits CYP3A4 adjunctive therapy with nefazodone and oxidatively metabolized BZD contraindicated; BZD metabolized by glucuronidation (e.g., temazepam) may be acceptable alternative; monitor for signs of BZD intoxication and adjust doses if needed contraindicated (triazolam), moderate (estazolam) (Micromedex), 1-contraindicated (triazolam), 3-moderate (estazolam) (CP)
oxidatively metabolized BZDs (e.g., estazolam, triazolam) non-nucleotide reverse transcriptase (NNRT) inhibitors potential for altered serum concentrations and pharmacologic effects in oxidatively metabolized BZDs (metabolized by CYP3A4); delavirdine, efavirenz inhibit CYP3A4 and magnify oxidative BZD pharmacologic/ adverse effects, while nevirapine induces oxidative BZD metabolism and diminishes pharmacologic effects adjunctive therapy with NNRT inhibitors and oxidatively metabolized BZD contraindicated; BZD metabolized by glucuronidation (e.g., temazepam) may be acceptable alternative contraindicated (DrugReax), 1-contraindicated, 3-moderate (CP)
oxidatively metabolized BZDs (e.g., estazolam, triazolam) protease inhibitors potential for increased serum concentrations and enhanced pharmacologic/ adverse effects (e.g., severe sedation, respiratory depression) in oxidatively metabolized BZDs (metabolized by CYP3A4) as protease inhibitors inhibit CYP3A4 adjunctive therapy with protease inhibitors and oxidatively metabolized BZD contraindicated; BZD metabolized by glucuronidation (e.g., temazepam) may be acceptable alternative triazolam: contraindicated, estazolam: moderate (Micromedex), triazolam: 1-contraindicated, estazolam: 3-moderate (CP)
oxidatively metabolized BZDs (e.g., estazolam, triazolam) triazole antifungals (e.g., fluconazole, voriconazole) potential for increased serum concentrations and enhanced pharmacologic/ adverse effects in oxidatively metabolized BZDs (metabolized by CYP3A4) as triazole antifungals inhibit CYP3A4 adjunctive therapy with triazole antifungals and oxidatively metabolized BZD not recommended; BZD metabolized by glucuronidation (e.g., temazepam) may be acceptable alternative major (DrugReax), 3-moderate (CP)
ramelteon antifungal agents (triazoles or imidazoles) potential for increased ramelteon serum concentrations and increased clinical/adverse effects due to CYP2C9 inhibition by triazole antifungals (e.g., fluconazole, voriconazole) or CYP3A4 inhibition by imidazole antifungals (e.g., itraconazole, ketoconazole) cautiously administer therapy concurrently; monitor for enhanced ramelteon pharmacologic/adverse effects moderate (DrugReax), 3-moderate (CP)
ramelteon fluvoxamine fluvoxamine inhibition of ramelteon metabolism (CYP1A2) and potential for increased ramelteon serum concentrations and increased clinical/adverse effects avoid concurrent administration; other selective serotonin reuptake inhibitors (e.g., citalopram, fluoxetine) may be safer alternatives to fluvoxamine contraindicated (DrugReax), 1-contraindicated (CP)
ramelteon strong CYP1A2 inducers (e.g., rifampin, rifabutin) induction of ramelteon metabolic clearance (CYP1A2) with potential for decreased ramelteon clinical effects monitor for decreased ramelteon effectiveness minor (DrugReax), 3-moderate (CP)
sedative/hypnotics sodium oxybate (Xyrem®) adjunctive administration may result in additive central nervous system (CNS) depression concurrent administration contraindicated Contraindicated, major (Micromedex) 1-contraindicated (CP)
suvorexant CNS depressants adjunctive administration may result in additive CNS depression, cognitive/ behavioral changes, and complex sleep behaviors combined administration not recommended; if necessary, monitor for residual CNS depressant effects major (DrugReax), 3-moderate (CP)
suvorexant strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin) potential for increased suvorexant serum levels and increased pharmacologic/ adverse effects and toxicity as suvorexant is CYP3A4 substrate combined administration not recommended major (Micromedex), 2-major (CP)
suvorexant moderate CYP3A4 inhibitors (e.g., fluconazole, aprepitant, ciprofloxacin) potential for increased suvorexant serum levels and increased pharmacologic/ adverse effects as suvorexant is CYP3A4 substrate administer together cautiously, observing for increased adverse effects; suvorexant dose should be reduced to 5 mg/day, but may be increased to maximum of 10 mg/day to maintain efficacy moderate (DrugReax), 2-major (CP)
suvorexant CYP3A4 inducers (e.g., carbamazepine, rifampin) combined administration may result in reduced suvorexant serum levels and decreased efficacy as suvorexant is CYP3A4 substrate monitor for decreased suvorexant efficacy and adjust dosages as needed 3-moderate (CP)
TCAs (e.g., doxepin) monoamine oxidase inhibitors (MAOIs) increased risk of serotonin syndrome (e.g., mental status changes, hyperpyrexia, restless, shivering) due to serotonin metabolism inhibition by monoamine oxidase allow 14 days after MAOI discontinuation before initiating other antidepressant therapy; wait 5 weeks after discontinuing fluoxetine before initiating MAOIs major (Micromedex), 1-contraindicated (CP)
TCAs (e.g., doxepin) drugs other than MAOIs with serotonergic activity (e.g., tramadol, sumatriptan, nefazodone, trazodone) increased risk of serotonin syndrome (e.g., mental status changes, hyperpyrexia, restless, shivering, hypertonia, tremor) due to additive serotonergic effects use cautiously together; if adjunctive administration necessary, monitor for signs and symptoms of serotonin syndrome major (DrugReax), 2-major, 3-moderate (CP)
TCAs (e.g., doxepin) drugs that prolong QT interval increased risk of somnolence, bradycardia, and serious cardiotoxicity (QT prolongation, Torsades de pointes) due to potential additive effects on QT interval avoid concurrent use; if adjunctive use necessary, monitor for increased pharmacologic/toxic effects; adjust dose as necessary contraindicated, major (Micromedex), 1-contraindicated, 2-major (CP)
zolpidem CYP3A4 inhibitors (e.g., ketoconazole, protease inhibitors) potential for increased zolpidem serum concentrations and enhanced pharmacologic/ adverse effects (e.g., severe sedation, respiratory depression) with concurrent administration of CYP3A4 inhibitors, as zolpidem is metabolized by CYP3A4 monitor patients for enhanced zolpidem effects; adjust doses as necessary major (Micromedex), 3-moderate (CP)
zolpidem CYP3A4 inducers (e.g., carbamazepine, rifampin) induction of zolpidem metabolic clearance (CYP3A4) with potential for decreased zolpidem clinical effects monitor for decreased zolpidem effectiveness moderate (DrugReax), 2-major (CP)

Legend:

  • # Clinical Pharmacology

5. References

  1. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc; 2022. Available at: http://www.clinicalpharmacology-ip.com.ezproxy.lib.utexas.edu. Accessed December 8, 2022.
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  4. Flurazepam oral capsules package insert. Mylan Pharmaceuticals Inc., February 2021. 
  5. Temazepam (Restoril®) oral capsules package insert. SpecGx LLC, February 2021.
  6. Triazolam (Halcion®) oral tablets package insert. Pharmacia & Upjohn Company LLC, October 2021.
  7. Quazepam (Doral®) oral tablets package insert. Galt Pharmaceuticals, LLC, January 2021. 
  8. Phenobarbital oral tablets package insert. e5 Pharma LLC, November 2022.
  9. Phenobarbital oral elixir package insert. e5 Pharma LLC, November 2022.  
  10. Eszopiclone (Lunesta®) oral tablets package insert. Sunovion Pharmaceuticals Inc., August 2019.
  11. Eszopiclone oral tablets package insert. Aurobindo Pharma Limited, December 2021.
  12. Zaleplon oral capsules package insert. Aurobindo Pharma Limited, December 2021. 
  13. Zolpidem immediate-release (Ambien ®) oral tablets package insert. Sanofi Aventis U.S., February 2022.
  14. Zolpidem extended-release (Ambien CR®) package insert. Sanofi Aventis U.S., February 2022.
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  16. Zolpidem sublingual tablets package insert. Par Pharmaceutical Inc., October 2019.
  17. Zolpidem oral spray (Zolpimist®) package insert. Aytu BioPharma Inc., August 2019.
  18. Ramelteon oral tablets (Rozerem®) package insert. Takeda Pharmaceuticals America Inc., November 2021.
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  20. Daridorexant oral tablets (Quviviq®) package insert. Idorsia Pharmaceuticals US Inc., April 2022.
  21. Lemborexant oral tablets (Dayvigo®) package insert. Eisai Inc., June 2022.
  22. Suvorexant oral tablets (Belsomra®) package insert. Merck & Co., Inc., May 2022.
  23. Doxepin oral tablets (Silenor®) package insert. Currax Pharmaceuticals LLC, October 2020.
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